UK must address regulatory and funding issues to realise promise of regenerative medicine, says expert

Life sciences specialist Helen Cline of Pinsent Masons, the law firm behind Out-Law.com, said that regenerative medicine is the "future of medicine" and welcomed proposals to make navigating the regulatory environment easier.

A new report published by the Regenerative Medicine Expert Group (RMEG) (40-page / 4.17MB PDF) sets out what additional steps are necessary to help researchers develop and clinicians utilise technologies that improve the human body's ability to repair itself. The RMEG is tasked with developing an NHS regenerative medicine strategy.

In its report, RMEG defined 'regenerative medicine' as "methods that replace or regenerate human cells, tissues or organs in order to restore or establish normal function".

"The nature of regenerative medicine research involves creating personalised precision therapies that may provide a cure rather than merely alleviating symptoms but there is often a high up-front cost associated with these individualised therapies which raises challenges around evaluation, funding and adoption," Cline said.

Cline said that "unnecessary, excessively complex or burdensome regulation" together with "unclear evaluation and funding pathways could stifle the promise of regenerative medicine". However, she said moves to streamline regulation to enable innovation must not "put patients at risk of harm and damage the reputation of this field of research at a crucial point in its history".

"Regulation in the area of regenerative medicines is complex, reflecting the nature of the technologies and their risks," Cline said. "For example, in the UK there are four regulatory bodies each regulating distinct aspects of the development of regenerative medicine under different pieces of legislation."

Cline said there have already been steps taken towards the "streamlining of regulatory advice", with a single point of access for advice on regenerative medicine rules available from the Innovation Office within the Medicines and Healthcare Products Regulatory Agency (MHRA).

Regulators have also collaborated on providing guidance on regenerative medicines issues, including developing the UK Stem Cell Tool Kit to provide clear guidance on the regulatory pathways that must be followed in developing a regenerative product derived from stem cells, Cline said.

However, the RMEG's report said that "further steps are needed to ensure that standardisation of processes, and streamlined regulation, are guiding principles in advancing regenerative medicine".

The RMEG also identified funding issues as a barrier to the growth of regenerative medicines, and called on the UK government and industry to come together to develop "an innovative business model that supports the early adoption of regenerative medicines". It also called for reviews to be carried out on "the funding for excess treatment costs for cell therapy trials" with the aim of finding "a mechanism … to ensure that meeting of these costs is not a barrier to clinical trials or the early adoption of technologies".

Cline said: "While debate in the past has been on the legality of funding of research, at least in the US, debate today is how best to regulate the clinical translation and commercialisation of these innovative technologies."

The expert said that ethical and patent issues have also been a factor in the development of regenerative medicines. She highlighted a ruling by the Court of Justice of the EU (CJEU) last year on the patentability of inventions stemming from human embryonic stem cell research as an example of a case that highlights the divergent opinions on the issues.

"Research in the field of regenerative medicine and particularly human embryonic stem cell research is emotive," Cline said. "The debates around regulation and commercialisation include a diversity of opinion on the many ethical, regulatory and legal considerations, such as patient consent in clinical trials as the line between research and treatment is blurred in this area of medicine."

The RMEG's report concluded that the UK has the "industrial base, the academic excellence and the clinical know-how that is necessary" as well as previous experiences of success in advanced medicine and treatments to "consolidate and build upon its position as a world leader in regenerative medicine".